1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
  6. Subpart B - Clinical Chemistry Test Systems
  7. 21 CFR § 862.1495
21 CFR § 862.1495
Magnesium test system
June 25, 2020
CFR

(a) Identification. A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

(b) Classification. Class I.

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§ 862.1490 Lysozyme (muramidase) test system
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§ 862.1500 Malic dehydrogenase test system

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